Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Patient consent

• Chronic alcohol intake in the last 3 to 6 months

• Maddrey score ≥ 32

• Liver histology compatible

Exclusion Criteria:

• Hepato renal syndrome

• Hepatocarcinoma

• Recent variceal haemorrhage

• Recent bacterial infections

• Other liver diseases associated (HCV, HBV, hemochromatosis, AIH)

• Cancers or cardiac and respiratory, HIV infection

• NAC Allergy

• No patient consent

• Acetaminophen intoxication